§ 803.56 If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?

If you are a manufacturer, when you obtain information required under this part that you did not provide because it was not known or was not available when you submitted the initial report, you must submit the supplemental information to us within 30 calendar days of the day that you receive this information. You must submit the supplemental or followup report in accordance with the requirements of § 803.12(a) . On a supplemental or followup report, you must:

(a) Indicate that the report being submitted is a supplemental or followup report;

(b) Submit the appropriate identification numbers of the report that you are updating with the supplemental information (e.g., your original manufacturer report number and the user facility or importer report number of any report on which your report was based), if applicable; and

(c) Include only the new, changed, or corrected information.

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What FDA inspectors cite under § 803.56

Form FDA 483 observations citing this section, fiscal years 2010–2025 (Devices).

• Submission of Supplement to Individual Report Within One Month 58

Warning letters citing § 803.56

3 FDA warning letters since 2017 cite this section :

• Physitemp Instruments, LLC 12 Nov 2025
• Insung Medical Co. Ltd. 23 Sept 2025
• EpiCare Acquisitions, LLC 21 Mar 2025

FDA guidance that cites § 803.56

• Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers: Guidance for Industry and Food and Drug Administration Staff 29 Aug 2024
• Policy for Device Software Functions and Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff 28 Sept 2022
• Providing Submissions in Electronic Format — Postmarketing Safety Reports 27 Apr 2022
• Postmarketing Safety Reporting for Combination Products: Guidance for Industry and FDA Staff 22 Jul 2019
• Compliance Policy for Combination Product Postmarketing Safety Reporting: Immediately in Effect Guidance for Industry and Food and Drug Administration Staff 20 Apr 2019
• Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration Staff 8 Nov 2016
• Infusion Pumps Total Product Life Cycle: Guidance for Industry and FDA Staff 2 Dec 2014

Amendment history

Federal Register documents that created or amended this section.

• 79 FR 8846 14 Feb 2014